The Value of Standardized Respiratory Rate Monitoring Exercises During Rheumatological Injection Procedures

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Metropole Savoie

About this trial

The goal of this clinical trial is to demonstrate the non-inferiority of standardized breathing control exercises on perceived pain during rheumatological injections procedures compared to standard care consisting of the addition of a local anesthetic. The study population will consist of patients scheduled to undergo therapeutic ultrasound-guided joint or periarticular injection. The main question it aims to answer is:

* Non-inferiority of breathing exercises compared to the addition of local anesthetic on pain and anxiety experienced during an infiltration procedure. * Correlation between the reduction in pain and anxiety experienced during a procedure and the cardiac coherence score obtained.

Researchers will compare the anesthesia group (Arm A), which will receive local anesthesia with 5 cc of lidocaine before the infiltration procedure to the breathing group (Arm B), which will receive instructions before the injection procedure on how to perform 5-minute breathing cycles to facilitate the achievement of cardiac coherence to see if the pain perceived in Arm B is not greater than the pain perceived in Arm A.

Participants will be kept blind to their randomization group. Arm A (anesthesia) will receive SHAM breathing exercises, while Arm B (breathing) will receive a placebo injection of anesthetic.

Eligibility criteria

Qualifiers

Patient scheduled to undergo therapeutic ultrasound-guided joint or periarticular injection.

Patient able to sign an informed consent form to participate in the study

Disqualifiers

Patient able to sign an informed consent form to participate in the study - - Allergy to the injection product or anesthetic.

Injection not allowing the use of a local anesthetic due to insufficient joint volume (e.g., fingers/toes).

Epidural injection via the sacrococcygeal hiatus.

Pregnant women

Trial design

Treatments tested in this trial

  • Anesthesia
  • breathing group

Treatment groups

136 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Centre Hospitalier Metropole Savoie

Lead sponsor

Université Savoie Mont Blanc

Collaborator